Botulinum Toxin for Stomach Cancer Treatment
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ClinicalTrials.gov Identifier: NCT01822210 |
Recruitment Status :
Completed
First Posted : April 2, 2013
Last Update Posted : March 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Stomach Neoplasms | Drug: Botox | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Botulinum Toxin (BOTOX) for Stomach Cancer Treatment |
Actual Study Start Date : | January 2013 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Botox
Injection of Botox in the tumor and surrounding stomach wall.
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Drug: Botox
injection by gastroscopy (100 Allergen units)
Other Name: Botulinum toxin |
- Change of tumor volume in the stomach. [ Time Frame: Baseline and 8 weeks ]Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
- Change of tumor volume in the stomach. [ Time Frame: 8 weeks and 20 weeks ]Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).
- Toxicity [ Time Frame: 2 weeks ]Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Toxicity [ Time Frame: 8 weeks ]Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- performance status [ Time Frame: 2 weeks ]ECOG scale
- performance status [ Time Frame: 8 weeks ]ECOG scale
- performance status [ Time Frame: 20 weeks ]ECOG scale

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Patients with verified gastric adenocarcinoma but found non-resectable or inoperable after evaluation in the appropriate multidisciplinary team at St.Olav Hospital. Trondheim University Hospital. The inclusion criteria for such patients are:
- Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy.
- Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.
- Patients who, after meticulous information about chemotherapy, still do not want such treatment.
- Patients with performance status (ECOG) 0-2.
Exclusion criteria:
- Known allergy to any of the components in Botox®
- Known peripheral motor neuropathy disease ( for example: Amyotrophic Lateral Sclerosis, ALS), or subclinical or clinical deficiency of neuromuscular transmission (for example: Myasthenia Gravis or Eaton-Lambert's Syndrome).
- Pregnant or lactating women.
- Another cancer disease that is not under control.
- Another concomitant treatment for cancer.
- Serious mental illness.
- Performance status (ECOG) 3-4.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822210
Norway | |
Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital | |
Trondheim, Norway |
Principal Investigator: | Jon Erik Grønbech, MD. PhD. | St. Olavs Hospital |
Responsible Party: | St. Olavs Hospital |
ClinicalTrials.gov Identifier: | NCT01822210 |
Other Study ID Numbers: |
StOlav2205 2012-002493-31 ( EudraCT Number ) |
First Posted: | April 2, 2013 Key Record Dates |
Last Update Posted: | March 9, 2018 |
Last Verified: | March 2018 |
Botulinum Toxins Injections Stomach Tomography, X-Ray Computed |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Botulinum Toxins Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |